Product code NFM— Ophthalmic
ORBITAL TISSUE EXPANDER (OTE)
- Classification name
- Expander, Tissue, Orbital
- Device class
- Class 2
- Regulation
- 21 CFR 886.3320
- Advisory panel
- Ophthalmic
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code NFM
FDA has cleared devices under product code NFM between 2001 and 2006, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2006
- 2001
Top applicants under product code NFM
Recent clearances under product code NFM
Data sourced from openFDA. This site is unofficial and independent of the FDA.